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NCT Number: NCT00766623

Elucidation and Monitoring Postprandial Endothelial Function

The primary aim of this study is to evaluate the effect of a high fat challenge on several measures of endothelial function. The secondary aim of this study is to elucidate the mechanism of postprandial endothelial dysfunction and to identify early biomarkers

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Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen universiteit division of human

Wageningen, Gelderland, 6703HD, Netherlands

About this study

Endothelial dysfunction (ED) is a hallmark for the initial stage of vascular dysfunction and has been associated with diet-related disorders such as cardiovascular disease. This makes prevention of ED an important health target. From previous studies we know that a high-fat (HF) meal (challenge) impairs postprandial endothelial function (EF). Current studies only evaluated the effect of a HF meal on Flow Mediated Dilatation (FMD), a measure of macro vascular EF. This methodology (FMD) however, is time consuming and large variations in reproducibility are reported in literature. The question remains whether other types of macro- and micro vascular EF measurements can be used to observe ED after a HF meal that are more accurate, faster and easier to perform. In addition, it is know that the postprandial phase results in activation of leukocytes. This activation of leukocytes is likely to contribute to ED, but the exact underling mechanism remains unclear.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male, caucasian

Exclusion criteria

• Allergic to cow milk or dairy products

  • Body mass index (BMI) < 18 or > 25 kg/m2
  • Urine glucose concentrations outside normal ranges (>0,25 g/l)
  • Fasting blood glucose outside the normal range (3 - 5.5 mmol/L)
  • Tobacco smoking
  • Taking medication or food supplements.
  • Received inoculations within 2 months of starting the study or planned to during the study
  • Donated or intended to donate blood from 2 months before the study till two months after the study
  • Blood Hb values below 8.4 mmol/L
  • Diagnosed with any long-term medical condition (e.g., diabetes, hemophilia, cardiovascular disease, anemia, gastrointestinal disease, renal failure)
  • High blood pressure (systolic BP> 140 mmHg and/or diastolic BP>90 mmHg)

Treatment and study plan

High fat meal

Dietary Supplement

milkshake containing 95g fat

Control meal

Dietary Supplement

milkshake comparable with a normal breakfast

Primary outcomes

  1. Macrovascular local arterial stiffness by echo-tracking

    Time frame: 0, 3, 6 hours

  2. Macrovascular regional arterial stiffness by tonometry

    Time frame: 0, 3, 6 h

  3. Macrovascular circulation by flow mediated dilatation

    Time frame: 0, 3, 6h

  4. Microvascular circulation by iontophoresis/laser doppler

    Time frame: 0, 3, 6h

Secondary outcomes

  1. PBMC gene expression profiles

    Time frame: 0, 1, 2, 3, 5, 6 hours

  2. Leukocyte activation markers

    Time frame: 0, 3, 6h

  3. cytokine profiles

    Time frame: 0, 1, 2, 3, 5, 6 hours

  4. known plasma markers of ED

    Time frame: 0, 1, 2, 3, 5, 6 hours

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Acronym: EMPEF

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 6, 2008
Registry last updated
Sep 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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